Overview

This trial is active, not recruiting.

Conditions wound infection, wound complication
Treatments subcuticular suture, staple closure
Phase phase 2
Sponsor Washington University School of Medicine
Start date May 2013
End date September 2016
Trial size 162 participants
Trial identifier NCT01977612, 201304058

Summary

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
All patients will undergo a surgical proceduure for treatment/diagnosis of their disease as part of standard care. They will be randomized pre-operatively to closure with either staples or sutures. In one arm the patients will have their skin closed with steel staples.
staple closure
Staples will be used instead of sutures in closing the incision in one arm of the study.
(Experimental)
All patients will undergo a surgical proceduure for treatment/diagnosis of their disease as part of standard care. They will be randomized pre-operatively to closure with either staples or sutures. In the second arm, patients will have their skin closed with subcuticular sutures.
subcuticular suture
Subcuticular suture will be used instead of staples in closing the skin of patients enrolled in one arm of this study.

Primary Outcomes

Measure
Composite of wound disruption or infection occurring within 4-8 weeks of the date of the primary surgery.
time frame: 4-8 weeks post-surgery

Secondary Outcomes

Measure
Incidence of wound disruption within 4-8 weeks of the date of the primary surgery.
time frame: 4-8 week post-surgery
Incidence of wound infection within 4-8 weeks of the date of the primary surgery.
time frame: 4-8 weeks post-surgery
Operative time
time frame: During surgery
Analog pain score on postoperative days 3-4
time frame: 3-4 days post-op
Cosmesis score
time frame: 4-8 weeks post-operative
Patient satisfaction score
time frame: 4-8 weeks post-operative

Eligibility Criteria

Female participants from 18 years up to 85 years old.

Inclusion Criteria: - All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy. - Body mass index >=30 - Benign or oncologic indications for surgery. - Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery. - Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine. - Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: - Women who are pregnant or breastfeeding - Pfannenstiel or transverse abdominal incision - Concomitant panniculectomy or plastic surgery - Women <18 years of age - History of prior abdominal or pelvic radiation - Inability to sign an informed consent form prior to registration on study - Inability to understand spoken or written English - Prisoner - Mental incapacity - A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.

Additional Information

Official title Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
Principal investigator Lindsay Kuroki, M.D.
Description The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in June 2016.